恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163152363151303152983151983149033151530.05
211.133156613157393157000.02
单位质量响应值RSD%判断
28239.5228364.780.32数据可信
供试品溶液-6010901批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154600-5460086.81472.9219.9786.8172.9219.97
247124-4712474.92774.93
352242-5224283.06483.06
430805-3080548.98048.98
539150-3915062.24862.25
651241-5124181.47381.47
10min159725-5972594.96290.848.0495.9391.658.13
259353-5935394.37195.20
359959-5995995.33496.26
448121-4812176.51277.06
556497-5649789.83090.52
659147-5914794.04394.95
15min158900-5890093.65193.413.1995.6795.233.35
259078-5907893.93495.81
360786-6078696.64998.63
455203-5520387.77289.17
559017-5901793.83795.53
659521-5952194.63896.59
20min158383-5838392.82993.131.7295.8995.991.90
258949-5894993.72996.65
359134-5913494.02397.08
456629-5662990.04092.41
559002-5900293.81396.55
659340-5934094.35097.35
30min160918-6091896.85997.511.54100.95101.401.60
260415-6041596.059100.03
361359-6135997.560101.66
460454-6045496.12199.49
561996-6199698.573102.35
662810-6281099.867103.92
45min159065-5906593.91395.531.0299.08100.501.01
260175-6017595.678100.71
360467-6046796.142101.33
460160-6016095.654100.09
559786-5978695.05999.93
660828-6082896.716101.88
60min158250-5825092.61793.501.2798.8399.531.31
258778-5877893.45799.55
358332-5833292.74799.00
458048-5804892.29697.80
559536-5953694.662100.59
659873-5987395.198101.43
90min158527-5852793.05893.180.87100.30100.260.82
258472-5847292.970100.11
357820-5782091.93399.22
458757-5875793.42399.95
558649-5864993.252100.23
659386-5938694.423101.72
120min157510-5751091.44192.051.1599.71100.161.01
258723-5872393.369101.54
356789-5678990.29498.60
458048-5804892.29699.86
558162-5816292.477100.49
658124-5812492.417100.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限157441-5744191.33191.091.43100.62100.231.44
257338-5733891.167100.37
357137-5713790.847100.16
457184-5718490.92299.51
556045-5604589.11198.15
658605-5860593.182102.55
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004087204087354085994081614081254084680.08
211.024076514079894078200.06
单位质量响应值RSD%判断
37133.4537007.260.25数据可信
供试品溶液-6010901批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118846-1884622.85418.6712.2222.8518.6712.22
213791-1379116.72416.72
314666-1466617.78517.79
414524-1452417.61317.61
516239-1623919.69319.69
614299-1429917.34017.34
10min132436-3243639.33536.686.7039.5936.886.71
230094-3009436.49536.68
330811-3081137.36437.56
428422-2842234.46734.66
532278-3227839.14339.36
627430-2743033.26433.46
15min141496-4149650.32247.985.9851.0148.605.99
237901-3790145.96246.55
341038-4103849.76750.38
438481-3848146.66647.24
542235-4223551.21851.87
636256-3625643.96844.53
20min148001-4800158.21156.014.9859.4657.165.00
244049-4404953.41854.52
346222-4622256.05357.22
446366-4636656.22857.33
549279-4927959.76160.98
643202-4320252.39153.44
30min160812-6081273.74772.025.0075.6473.794.97
254012-5401265.50067.20
359703-5970372.40274.19
459499-5949972.15473.88
562975-6297576.37078.26
659303-5930371.91773.55
45min169380-6938084.13782.794.7286.8585.364.70
262239-6223975.47777.90
370408-7040885.38487.98
468380-6838082.92485.45
571336-7133686.50989.24
667876-6787682.31384.75
60min171804-7180487.07787.724.8890.7391.224.82
266022-6602280.06583.33
373868-7386889.58093.12
471700-7170086.95090.40
576203-7620392.41196.11
674421-7442190.25093.60
90min176045-7604592.22093.163.1496.8497.623.12
272633-7263388.08292.23
376962-7696293.33297.87
477011-7701193.39197.80
578990-7899095.791100.51
679281-7928196.144100.49
120min177205-7720593.62693.721.4599.2799.221.51
275745-7574591.85696.99
376227-7622792.44098.01
477789-7778994.33599.78
578567-7856795.278101.07
678180-7818094.809100.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限176622-7662292.91993.581.3399.60100.131.12
277518-7751894.006100.16
377832-7783294.387100.99
476699-7669993.01399.51
575740-7574091.85098.70
678608-7860895.328101.80
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163159333154923156743157943157843157350.06
211.133161173163513162340.06
单位质量响应值RSD%判断
28291.6728412.760.31数据可信
供试品溶液-6010902批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152126-5212682.73473.9321.4482.7373.9321.45
251201-5120181.26581.27
355657-5565788.33888.34
451529-5152981.78681.79
529652-2965247.06347.06
639297-3929762.37262.37
10min160796-6079696.49490.3410.6697.4191.1610.75
260485-6048596.00196.90
360184-6018495.52396.50
459871-5987195.02695.94
545419-4541972.08872.61
654757-5475786.90987.60
15min161906-6190698.25694.653.72100.2596.483.93
260764-6076496.44498.41
360534-6053496.07998.12
460636-6063696.24198.21
555920-5592088.75590.08
658041-5804192.12293.78
20min160636-6063696.24196.080.8799.3298.961.05
261067-6106796.92599.97
360944-6094496.72999.84
459931-5993195.12298.16
559848-5984894.99097.30
660792-6079296.48899.17
30min160435-6043595.92295.631.37100.0799.581.49
260776-6077696.463100.58
360071-6007195.34499.53
459912-5991295.09199.18
558955-5895593.57296.94
661367-6136797.401101.16
45min159917-5991795.09993.101.42100.3298.111.49
258279-5827992.50097.69
358956-5895693.57498.82
457656-5765691.51196.66
558021-5802192.09096.50
659110-5911093.81998.66
60min159230-5923094.00994.861.16100.28100.910.88
260047-6004795.306101.52
359843-5984394.982101.27
458974-5897493.60399.77
560925-6092596.699102.13
659596-5959694.590100.47
90min158416-5841692.71793.650.95100.04100.750.95
259216-5921693.987101.26
359528-5952894.482101.82
458437-5843792.75099.95
558724-5872493.20699.71
659713-5971394.776101.71
120min158760-5876093.26392.480.96101.61100.611.15
257833-5783391.792100.11
358801-5880193.328101.72
458536-5853692.907101.14
557404-5740491.11198.65
658258-5825892.466100.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限156776-5677690.11490.450.6899.5099.620.66
257461-5746191.201100.54
356793-5679390.14199.57
456522-5652289.71198.98
556929-5692990.35798.91
657455-5745591.192100.20
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004080924079554078094080874079934079870.03
211.024081134084484082800.06
单位质量响应值RSD%判断
37089.7337049.000.08数据可信
供试品溶液-6010902批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114732-1473217.86614.1922.4317.8714.1922.46
212043-1204314.60514.60
313936-1393616.90116.90
410748-1074813.03413.03
57326-73268.8848.88
611416-1141613.84413.84
10min126027-2602731.56427.3718.3831.7627.5318.38
225693-2569331.15931.32
325752-2575231.23031.42
422121-2212126.82726.97
515625-1562518.94919.05
620187-2018724.48124.64
15min135259-3525942.76037.7214.0343.3138.1814.09
234236-3423641.51942.03
334285-3428541.57842.11
431001-3100137.59638.04
524466-2446629.67129.98
627379-2737933.20333.63
20min141220-4122049.98945.6911.2251.0146.5811.31
241528-4152850.36251.33
340988-4098849.70750.70
436826-3682644.66045.52
531820-3182038.58939.23
633693-3369340.86041.66
30min150435-5043561.16457.477.3662.7458.867.51
250979-5097961.82463.35
349619-4961960.17461.72
444941-4494154.50155.86
542303-4230351.30252.37
646057-4605755.85557.10
45min160357-6035773.19769.363.8075.4671.393.96
258331-5833170.74072.96
357789-5778970.08272.30
454292-5429265.84167.80
555349-5534967.12368.76
657064-5706469.20371.07
60min165081-6508178.92578.932.3182.0081.732.19
266463-6646380.60183.60
364334-6433478.02081.02
462923-6292376.30879.00
567068-6706881.33583.72
664648-6464878.40081.04
90min168972-6897283.64484.021.9387.5987.701.94
270519-7051985.52089.42
370004-7000484.89688.76
466765-6676580.96884.51
569842-6984284.69987.99
669599-6959984.40587.91
120min171198-7119886.34484.391.4391.2289.001.56
269694-6969484.52089.37
369838-6983884.69489.50
468274-6827482.79887.24
569680-6968084.50388.73
668859-6885983.50787.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限167336-6733681.66082.981.6387.5088.531.52
269773-6977384.61690.40
368404-6840482.95588.70
467110-6711081.38686.75
569626-6962684.43789.60
668316-6831682.84988.22
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163166563164953164893160623162103163820.08
211.133169173169833169500.02
单位质量响应值RSD%判断
28349.6428477.090.32数据可信
供试品溶液-6010903批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131566-3156649.99361.6613.0649.9961.6613.06
246661-4666173.90073.90
337802-3780259.87059.87
439452-3945262.48362.48
541678-4167866.00866.01
636453-3645357.73357.73
10min155220-5522087.45692.625.4788.0193.305.51
261775-6177597.83798.66
358393-5839392.48193.15
461305-6130597.09397.79
560071-6007195.13995.87
654117-5411785.70986.35
15min159397-5939794.07196.492.2095.6098.202.26
260954-6095496.53798.45
361199-6119996.92598.62
462710-6271099.318101.09
561893-6189398.02499.81
659376-5937694.03895.63
20min159727-5972794.59496.191.5897.1798.981.67
262166-6216698.457101.44
360214-6021495.36598.13
461666-6166697.665100.54
560437-6043795.71898.60
660199-6019995.34197.98
30min159823-5982394.74696.981.3598.37100.841.42
261297-6129797.080101.16
361038-6103896.670100.50
462332-6233298.720102.68
561608-6160897.573101.52
661300-6130097.085100.78
45min160310-6031095.51796.521.19100.19101.451.27
261837-6183797.936103.09
360154-6015495.270100.17
461783-6178397.850102.91
560705-6070596.143101.17
660861-6086196.390101.17
60min159523-5952394.27195.991.43100.01101.991.45
261101-6110196.770103.01
360417-6041795.687101.65
461716-6171697.744103.89
559735-5973594.606100.70
661147-6114796.843102.69
90min159216-5921693.78594.711.48100.57101.781.48
261153-6115396.852104.17
358965-5896593.387100.41
460001-6000195.028102.26
559036-5903693.499100.65
660439-6043995.721102.65
120min158473-5847392.60893.220.93100.43101.341.01
259469-5946994.185102.58
358348-5834892.410100.47
459539-5953994.296102.58
558385-5838592.468100.65
658939-5893993.346101.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限158017-5801791.88692.131.26100.74101.291.24
258854-5885493.211102.65
357024-5702490.31399.40
458640-5864092.872102.21
557687-5768791.363100.58
658800-5880093.126102.15
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004091484084954086334082794081284085370.10
211.024092664090774091720.04
单位质量响应值RSD%判断
37139.7337129.950.02数据可信
供试品溶液-6010903批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18651-865110.47313.7127.9210.4713.7127.94
215295-1529518.51618.52
37329-73298.8728.87
412604-1260415.25815.26
514084-1408417.05017.05
69972-997212.07212.07
10min120954-2095425.36731.2711.6025.4831.4211.66
228307-2830734.26834.47
324661-2466129.85429.95
428632-2863234.66234.83
527857-2785733.72333.91
624551-2455129.72129.86
15min131022-3102237.55543.877.9937.9544.378.05
236738-3673844.47545.06
336017-3601743.60244.03
438657-3865746.79847.35
539135-3913547.37647.94
635871-3587143.42543.89
20min138188-3818846.23053.627.4547.0554.617.51
246282-4628256.02857.11
343808-4380853.03353.95
445964-4596455.64356.72
547476-4747657.47458.56
644050-4405053.32654.27
30min149746-4974660.22268.726.5261.5570.306.58
258058-5805870.28471.99
356911-5691168.89670.40
459416-5941671.92873.62
559988-5998872.62174.35
656489-5648968.38569.92
45min160271-6027172.96381.155.2574.9683.495.33
269764-6976484.45586.94
367848-6784882.13684.41
468608-6860883.05685.55
569279-6927983.86886.40
666412-6641280.39882.70
60min166884-6688480.96988.174.2283.7891.424.32
275857-7585791.83295.25
373526-7352689.01092.19
473940-7394089.51192.93
573722-7372289.24792.71
673064-7306488.45091.64
90min174149-7414989.76493.522.5893.4797.742.72
280069-8006996.931101.37
376766-7676692.93297.10
476808-7680892.98397.39
578565-7856595.11099.57
677140-7714093.38597.56
120min177746-7774694.11894.431.0898.8299.691.20
278604-7860495.157100.68
377639-7763993.98999.19
477451-7745193.76199.20
579398-7939896.118101.63
677164-7716493.41498.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限179168-7916895.84093.871.61101.59100.181.46
278068-7806894.508101.09
375946-7594691.93998.19
476680-7668092.82899.31
578546-7854695.087101.67
676814-7681492.99099.24
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163161083159953160343160283159403160210.02
211.133179713179663179680.01
单位质量响应值RSD%判断
28317.2928568.550.63数据可信
供试品溶液-6010904批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148360-4836076.51370.2413.3476.5170.2413.34
243974-4397469.57369.57
338044-3804460.19160.19
439993-3999363.27563.27
541948-4194866.36866.37
654072-5407285.55085.55
10min158677-5867792.83689.363.6993.6990.143.75
256188-5618888.89889.67
352939-5293983.75784.43
456467-5646789.33990.04
556126-5612688.80089.54
658495-5849592.54893.50
15min159670-5967094.40792.471.9296.2994.242.01
257558-5755891.06592.83
357471-5747190.92892.53
458177-5817792.04593.74
557775-5777591.40993.13
660023-6002394.96596.94
20min158309-5830992.25391.841.0495.1894.641.15
257469-5746990.92493.70
357430-5743090.86393.47
458149-5814992.00094.72
557888-5788891.58794.33
659045-5904593.41896.45
30min159447-5944794.05492.381.6398.0196.201.67
256857-5685789.95693.74
358080-5808091.89195.51
458801-5880193.03296.77
557989-5798991.74795.50
659160-5916093.60097.67
45min158827-5882793.07393.941.1898.0798.781.16
258631-5863192.76397.55
358845-5884593.10197.74
460349-6034995.481100.26
559790-5979094.59799.37
659795-5979594.60499.72
60min158615-5861592.73892.810.8998.7798.700.95
258181-5818192.05197.86
358047-5804791.83997.51
459425-5942594.01999.85
558612-5861292.73398.56
659069-5906993.45699.62
90min158481-5848192.52691.931.3999.5998.851.45
257099-5709990.33997.17
357344-5734490.72797.42
458724-5872492.91099.79
557851-5785191.52998.39
659134-5913493.559100.76
120min156715-5671589.73190.420.6197.8298.360.53
257637-5763791.19099.03
357006-5700690.19297.90
457484-5748490.94898.86
557004-5700490.18998.06
657050-5705090.26198.50
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限157857-5785791.53889.161.77100.6398.111.78
255903-5590388.44797.30
355096-5509687.17095.88
456460-5646089.32898.25
555731-5573188.17597.05
657082-5708290.31299.56
恩格列净非奈利酮片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.004083294083784080884078564079324081170.06
211.024105204105114105160.01
单位质量响应值RSD%判断
37101.5537251.910.29数据可信
供试品溶液-6010904批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117680-1768021.37915.3433.5521.3815.3433.55
211511-1151113.91913.92
37683-76839.2919.29
413163-1316315.91715.92
58635-863510.44210.44
617434-1743421.08221.08
10min133625-3362540.66032.6122.6440.9032.7822.69
226519-2651932.06832.22
320211-2021124.44024.54
426483-2648332.02432.20
520584-2058424.89125.01
634393-3439341.58941.82
15min143902-4390253.08845.4018.1653.7845.9318.25
238207-3820746.20146.71
330751-3075137.18537.56
436690-3669044.36744.90
529360-2936035.50335.90
646358-4635856.05756.75
20min150255-5025560.77054.6014.6862.0555.6414.80
246997-4699756.83057.85
339604-3960447.89048.68
444972-4497254.38155.41
535646-3564643.10443.89
653448-5344864.63165.95
30min161792-6179274.72168.8611.3376.6870.5111.48
258989-5898971.33172.99
353884-5388465.15866.48
456659-5665968.51470.14
546112-4611255.76057.03
664260-6426077.70579.74
45min171018-7101885.87784.205.3888.6686.615.64
271352-7135286.28188.73
369108-6910883.56785.61
468735-6873583.11685.51
563183-6318376.40378.29
674381-7438189.94492.84
60min175714-7571491.55690.873.4595.2994.223.73
276590-7659092.61596.02
375370-7537091.14094.11
474037-7403789.52892.84
570771-7077185.57888.31
678416-7841694.82398.72
90min178336-7833694.72695.692.4199.48100.042.66
279245-7924595.825100.26
379566-7956696.214100.20
478522-7852294.95199.26
576692-7669292.73896.42
682432-8243299.679104.63
120min178005-7800594.32695.941.37100.13101.361.41
280395-8039597.216102.72
380560-8056097.416102.47
478952-7895295.471100.84
578306-7830694.69099.41
679810-7981096.509102.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限179124-7912495.67995.900.61102.54102.390.85
278898-7889895.406101.99
379827-7982796.529102.67
478921-7892195.434101.86
579086-7908695.633101.40
680005-8000596.744103.88
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